1. Field of the Invention
This invention relates, generally, to laparoscopic instrumentation and use. More particularly, it relates to endoscopic devices for use in transvaginal laparoscopic surgeries, such as procedures to correct prolapse in female patients (e.g., sacrocolpopexy, sacrohysteropexy, and similar procedures).
2. Description of the Prior Art
Minimally invasive laparoscopic techniques have been developed in order to avoid large skin incisions associated with traditional surgery, involving use of small incisions (each about 5-12 mm in diameter) in the patient's abdominal wall, in which surgical instruments are inserted. These surgical instruments may be used to dissect and remove tissues and organs (i.e., specimens) that can be several centimeters in diameter. Such minimally invasive surgical techniques have been evolving for more than 100 years, since Georg Kelling performed the first experimental laparoscopy in 1901. (Litynski, G. Endoscopic surgery, the history, the pioneers. World J. Surg. 1999 August; 23(8):745-53). These minimally invasive laparoscopic surgeries result in less post-operative pain, quicker recovery and an improved cosmetic appearance for patients compared to traditional laparotomy. Currently, hybrid procedures combining flexible endoscopy and laparoscopy, such as intraoperative enteroscopy and laparoscopic-assisted endoscopic retrograde cholangiopancreatography, are performed in increasing numbers. (Ceppa, F., et al. Laparoscopic transgastric endoscopic retrograde endoscopy after Roux-en-Y gastric bypass. Surg. Obes. Relat. Dis. 3: 21-24 2007; Peters, M., et al. Laparoscopic transgastric endoscopic retrograde cholangiopancreatography for benign common bile duct structure after Roux-en-Y gastric bypass. Surg. Endosc. 16:1106 2002).
One limitation, however, has been the removal of pathologic specimens that are larger than the port sites used to perform these surgeries. Consequently, these large specimens typically must be removed from the abdominal cavity by cutting or morcellating them within the abdominal cavity or by making an incision in the abdominal wall that is large enough to accommodate removal of the large specimen.
Further, laparoscopic instruments are typically confined to fit within these port sizes, thus limiting development of larger and more efficient minimally invasive surgical devices. A typical umbilicus laparoscopic port incision is no larger than 15 mm, and other support incisions are usually much smaller. Larger incisions lead to more scarring and the potential for hernia formation. Therefore, the tools used for laparoscopy are small in size to fit these incision limitations.
Recently, surgeons have taken advantage of natural orifices (vagina, rectum, urethra, and gastrointestinal tract) to perform Natural Orifice Transluminal Endoscopic Surgery (NOTES) procedures with good results (Bessler, M.; Gumbs, A. A.; Milone, L.; Evanko, J. C.; Stevens, P.; Fowler, D. Video. Pure natural orifice transluminal endoscopic surgery (NOTES) cholecystectomy. Surg Endosc 24: 2316-2317; 2010; Kaouk, J. H.; White, W. M.; Goel, R. K.; Brethauer, S.; Crouzet, S.; Rackley, R. R.; Moore, C.; Ingber, M. S.; Haber, G. P. NOTES transvaginal nephrectomy: first human experience. Urology 74: 5-8; 2009; Pearl, J., Ponsky, J., Natural orifice transluminal endoscopic surgery: past present and future. J Min. Ace. Surg. 3:2 43-46 2008; Wilk, P., U.S. Pat. No. 5,297,536). NOTES has been used for diagnostic and therapeutic procedures including organ removal, though current articulating instruments for use with NOTES are disposable, increasing costs compared to standard laparoscopic procedures, and removal of large tumors or solid organs cannot be performed using NOTES (Dapri, Single access laparoscopic surgery: Complementary or alternative to NOTES? World J Gastrointest Surg. 2010 Jun. 27; 2(6): 207-9). Advantages of NOTES include cosmetic results; reduced anesthesia requirements; faster recovery and shorter hospital stays; decreased abdominal trauma and therefore potential complications of transabdominal wound infections, such as hernias; less need for immunosuppression and pain killers; and better postoperative pulmonary and diaphragmantic function.
NOTES has been extensively studied in animal models, with tubal ligation, gallbladder surgery, oophorectomy, hysterectomy, gastrojejunostomy, and splenectomy having been described. (Jagannath, S., et al. Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model. Gastrointest. Endosc. 61: 449-453 2005; Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis. Gastrointest. Endosc. 61: 601-606 2005; Wagh, M. et al., Survival studies after endoscopic transgastric oophorectomy and tubectomy in a porcine model. Gastrointest. Endosc. 63: 473-478 2008; Merrifield, B., et al. Peroral transgastric organ resection: a feasibility study in pigs. Gastrointest. Endosc. 63: 693-697 2006; Kantsevoy, S., et al. Transgastric endoscopic splenectomy: is it possible? Surg. Endosc. 20: 522-525 2006). These surgical procedures are promising advances, due to the potential to eliminate traditional surgical complications, like postoperative abdominal wall pain, wound infections, hernias, adhesions, and impaired immune function. (Wagh, M., Thompson, C. Surgery insight: natural orifice transluminal endoscopic surgery—an analysis of work to date. Gastr. & Hept. 4:7 386-392 2007). Further, NOTES procedures may be performed under conscious sedation and not general anesthesia. (Pearl, J., Ponsky, J., Natural orifice transluminal endoscopic surgery: past present and future. J Min. Ace. Surg. 3:2 43-46 2008). The transluminal approach could be particularly important for morbidly obese patients and others at high risk for standard surgery.
The vagina is an ideal portal to access the abdominal cavity for women undergoing minimally invasive laparoscopic surgery, and is regaining interest in the surgical community (Auyang, E. D.; Santos, B. F.; Enter, D. H.; Hungness, E. S.; Soper, N. J. Natural orifice translumenal endoscopic surgery (NOTES®): a technical review. Surg Endosc 25: 3135-3148; 2011; Stark, M.; Benhidjeb, T. Natural Orifice Surgery: Transdouglas surgery—a new concept. JSLS 12: 295-298; 2008) for peritoneal access. According to some computer generated models (Ashton-Miller, J. A.; DeLancey, J. O. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci 1101: 266-296; 2007), its elasticity allows stretching to accommodate dimensions greater than three times its resting state. The posterior portion of the vagina also directly communicates with the abdomen through only a few tissue layers, and when placed on stretch, is distant from vital anatomic structures. A laparoscopic port utilizing transvaginal access would increase the surgeon's access to the abdominal cavity and provide a much larger incision site, without the concerns for hernia formation and scarring. Additionally, transvaginal removal of large specimens enables minimally invasive laparoscopic surgery without the need for morcellation within the abdominal cavity or large incisions in the abdominal wall to remove the specimens, enabling minimal scarring and faster recovery following surgery. Accordingly, transvaginal NOTES is considered one of the safest and feasible methods for clinical application. Totally transvaginal cholecystectomy has been experimentally performed without using laparoscopic assistance.
Ghezzi et al. (Ghezzi, F.; Raio, L.; Mueller, M. D.; Gyr, T.; Buttarelli, M.; Franchi, M. Vaginal extraction of pelvic masses following operative laparoscopy. Surg Endosc 16: 1691-1696; 2002.) and Spuhler et al. (Spuhler, S. C.; Sauthier, P. G.; Chardonnens, E. G.; De Grandi, P. A new vaginal extractor for laparoscopic surgery. J Am Assoc Gynecol Laparose 1: 401-404; 1994) described devices for the extraction of pelvic masses following laparoscopy. These devices utilized a metal shaft with a fitted rubber ball to provide vaginal occlusion and prevent loss of pneumoperitoneum. Another device developed in Australia and marketed by Gynetech Pty Ltd, uses a similar hollow tube placed in the vagina (McCartney, A. J. Transvaginal tube as an aid to laparoscopic surgery. Google Patents; 2003). The design of this device is such that the tube fits around the cervix to distinguish the cervicovaginal junction, similar to the Koh colpotomy cup already in use for hysterectomy procedures (Koh, C. H. Simplified total laparoscopic hysterectomy method employing colpotomy incisions. Google Patents; 1996).
However, there is a need for an improved device that utilizes the vagina as an access to the peritoneal cavity for the introduction of laparoscopic surgical devices or implants, or the extraction of pathologic specimens. Accordingly, what is needed in the art is devices that permit enhanced access to the abdomen during surgery. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill how the art could be advanced.
While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein.
The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.
In this specification, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.